Therapeutic skin lifting device and related systems and methods

ABSTRACT

A therapeutic device has a bridge portion adapted for releasable adherence to a patch of skin so as to lift the patch of skin above a sensitive underlying treatment site in reducing discomfort or pain associated with tissue compression at the treatment site. The bridge portion is elevated above the treatment site with an exposed adhesive facing the patch of skin to be lifted and/or stretched outwardly. With the application of pressure to elastically deform the device from its original neutral configuration, the bridge portion is brought into contact with the patch of skin, adhering the skin to the adhesive. When the pressure is removed, the device rebounds and generally reassumes its original configuration with the bridge portion lifting the attached patch of skin.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/825,759, filed on Mar. 22, 2013, which is National PhasePatent Application and claims priority to and the benefit ofInternational Application Number PCT/US2013/28099, filed on Feb. 27,2013, which claims priority to and the benefit of U.S. ProvisionalApplication No. 61/685,545, filed on Mar. 20, 2012; U.S. ProvisionalApplication No. 61/685,752, filed on Mar. 22, 2012, and U.S. ProvisionalApplication No. 61/690,106, filed Jun. 19, 2012, the entire contents ofall of which are incorporated herein by reference.

FIELD OF INVENTION

The present invention relates to a medical device for reducing symptomsof physical ailments and conditions, including pain and discomfortassociated with Carpal Tunnel Syndrome (CTS), migraine headaches andother pressure-related ailments and conditions.

BACKGROUND

Carpal Tunnel Syndrome (CTS) is idiopathic median neuropathy at thecarpal tunnel of a human hand. With reference to FIG. 1, a human hand100 is illustrated with muscles in a proximate portion, below thumb 106and pinky finger 108, including abductor pollicis brevis 102 andabductor digit minimi 104, respectively. The muscles 102 and 104 definetransverse carpal arch 110 with a recess 112 therebetween that isgenerally aligned with third finger 114. In tissues below the recess 102is carpal tunnel 116 where median nerve 118 enters the hand 100. Thistunnel is normally narrow as it is also occupied by flexor tendons 120,so any swelling of adjacent tissue, including the flexor retinaculumligament 122, can pinch the nerve and cause pain, numbness, tingling orweakness.

The pathology of CTS is not completely understood but can be consideredcompression of the median nerve traveling through the carpal tunnel.Many studies have been conducted to identify causes but the evidence isnot clear. Various results published in the 1990's found strongassociations between the prevalence of CTS and forceful and repetitivewrist movements such as work on keyboard and computers. However, morerecent research has cited genetics and obesity as possibly largerfactors than use, and has encouraged caution in ascribing causality.

Pregnant women, especially those in their third trimester, mayexperience hand pain and discomfort, for example, numbness, tinglingsensation, or aching in the hands and wrists, particularly at night whenbodily fluids are more equally distributed throughout the body and notjust in the lower extremities. Because pregnancy causes swelling in manyparts of the body, extra pressure may be present on the nerves in thehands and wrists, including the median nerve.

The only scientific established disease modifying treatment is surgeryto cut or divide the transverse carpal ligament. However, one studyfound that within two years of surgery, 75% of the patients showedrecurrence of pain symptoms. Moreover, surgery has many risks and is notsuitable for temporary CTS, such as that experienced by pregnant women.Palliative treatments for CTS include use of night splints andcorticosteroid injection. Other nonsurgical treatment methods includehand braces, exercises, ergonomic equipment, oral diuretics andnonsteroidal anti-inflammatory drugs (NSAIDs). Websites includingwww.mycarpaltunnel.com discusses different treatment options. Otherapproaches include gloves, such as described in U.S. Pat. No. 6,006,751and the prior art cited therein. Obviously, such gloves may berelatively expensive and are not disposable. Gloves may also limitmanual dexterity and tactile sensitivity.

Kinesio tape has also been used as a nonsurgical treatment for CTS.Conventional kinesio tape is manufactured from a highly elastic strandwrapped in cotton fibers. It is employed as a gentle stretching therapyfor soft tissue disorders and repetitive strain injuries. Kinesio tapehas elasticity intended to match that of a person's skin, muscles,cartilage and connective fascia tissue. However, there are manydifferent methods of taping around the hand and wrist and impropertaping may cause further discomfort or even further damage to the mediannerve. Moreover, proper taping often requires the use of two handsmaking it difficult if not impossible for a patient to apply the tapewithout assistance.

Hand braces and splints and temporary, removable devices worn on thehand are also known, for example, a stretching hand device described inU.S. Pat. No. 6,315,748 and sold under the mark THE CARPAL SOLUTION. Thedevice includes a central, resilient, stretchable tensioning segmentwith a plurality of relatively less stretchable adhesive straps securedto the segment. In use, the segment is placed on the back of a patient'shand, whereupon the straps are pulled and adhered to the patient's palmin a fashion to expand the segment. In this orientation, the controlsegment exerts continuous yielding or tensile forces through the strapswhich in turn reduces carpal tunnel syndrome nerve compression andalleviates symptoms.

Another severe condition suffered by a significant portion of thepopulation is migraine headaches. The pain of migraine occurs whenexcited brain cells trigger the trigeminal nerve to release chemicalsthat irritate and cause swelling of blood vessels on the surface of thebrain. These swollen blood vessels send pain signals to the brainstem,an area of the brain that processes pain information. The pain ofmigraine is referred pain that is typically felt around the eye ortemple area.

In addition to prescription and over-the-counter drugs, there are manyremedies for migraines, including sleeping, taking caffeine, ice packs,and avoiding sunlight or certain foods. Kinesio tape has also been usedto alleviate severe headaches. Experts believe that taping cansignificantly help reduce headaches by repositioning the muscles thatare under stress and therefore helping to relieve tension in the neck.

Indeed, the adhesive tape or strips have many medical uses andapplications beyond bandaging wounds. For example, nasal snoring stripsare pieces of elastic plastic that are embedded in a sticking plasterfor attachment across the outside of the nose. Shape-memory causes theplastic to straighten which effectively widens the nasal passages toallow for improved airflow. These strips are disposable and simplisticin design, construction and use.

Accordingly, there is a desire for a device that can reduce the symptomsof pressure-related conditions and ailments, including CTS andmigraines. There is also a desire for the device to be simplistic indesign, construction and use and be able to lift skin above a sensitiveunderlying site.

SUMMARY OF THE INVENTION

The device of the present invention is primarily intended for use inthose suffering from Carpal Tunnel Syndrome (CTS), but also hasapplication for relieving migraine headaches and other situations wherelifting the skin and tissue above a sensitive underlying site wouldprovide benefits.

The present invention provides for an inexpensive, reliable and easy touse device which lifts an area of skin upwardly in a direction generallyperpendicular to the skin surface. It does not interfere with the sleepof the user and is a low cost disposable item. In a preferredembodiment, used for CTS, the device comprises a thin, generallyrectangular member with a long dimension and a short dimension. Themember is made from a plastic material, with “shape memory”, which inits normal configuration is generally flat. When pressure is appliedorthogonally to the member, the member deforms. When released frompressure, the “shape memory” member has spring and rebounds to itsnormal configuration as much as possible. On a bottom (skin-facing)surface of the device, adhesive or adhesion member (used interchangeablyherein) is provided on at least part of a central portion. A removableprotective cover (e.g., release liner of wax paper) is applied over theadhesive.

In use, the protective cover is removed and the adhesive is applied tothe palm proximate the wrist by a force depressing the center portion ofthe member toward the palm and fixes the center portion of the member tothe palm. The member is oriented with the long dimension of the memberacross the palm between the thumb and the pinky finger. Since theadhesive is applied to a concave portion of the palm, the device forms abridge across the palm. Side portions of the member supporting thecenter portion are not adhered to the palm so they can slide freely incontact with the palm. The skin of the palm adhering to the adhesive ofthe member is pulled upwardly as a result of negative pressure when themember is released and rebounds with its “shape memory”.

The adhesive can be applied to the device by any conventional means sothat the adhesive remains on the member when the protective backing isremoved. Alternatively, the adhesive can be applied by a user directlyto the member or to the palm or skin of the user. Lifting and/orstretching the skin in the area of the palm or treatment site relievessymptoms, including the symptoms of CTS.

While a preferred embodiment envisions use of a single piece ofspring-type plastic material, it is possible to incorporate otherdesigns to provide a resilient or shape-memory member, such as syntheticwhalebone, polyester boning material, metal, metal alloys, such asnitinol, and the like.

Accordingly, the present invention is directed a therapeutic deviceadapted for application to skin covering a treatment site on a patient'sbody, having a generally rigid but elastically deformable body with atleast one support portion and a bridge portion, the support portionadapted to rest on the skin, the bridge portion having an adhesiveadapted to adhere to at least a portion of the skin, wherein the body isadapted to assume a neutral configuration with the adhesive and theportion of the skin separated by an air gap, and an adhesionconfiguration with the portion of the skin adhering to the adhesivebeing lifted and/or stretched at the treatment site. The body is alsoadapted to assume a depressed configuration the wherein the body isdeformed from the neutral configuration with the bridge portion beingdepressed to bring the adhesive into contact with the portion of theskin.

The body while in its neutral configuration supports the bridge portionat a highest elevation relative to the skin surface of the treatmentsite, where as the body while in its depressed configuration supportsthe bridge portion at a lowest elevation. Moreover, the body while inits adhesion configuration supports the bridge portion at an in-betweenelevation greater than the lowest elevation and lesser than the greatestelevation. The adhesive provided on an inner, skin-facing surface mayinclude a coating or layer of adhesive material, double sided adhesivetape, at least one suction cup, and/or micro-suction cup tape.

In a more detailed embodiment, the therapeutic device has a thin sheetbody with a “butterfly” configuration wherein the support portionsupporting the bridge portion includes side planar portions adapted torest on the skin. The butterfly configuration is well-suited forapplication to a palm of the patient's hand with the device positionedon the palm and the bridge portion longitudinally aligned with a mediannerve of the palm. The adhesive is adapted for adhesion to skin belowthe device and above the median nerve.

The thin sheet body may also be configured rectangularly with roundedcorners and one or more curved edges. As such, the device is alsoadapted for application on other areas of the patient's body. Therounded corners are atraumatic and the curved edge(s) accommodatefeatures, curves and contours of the face or body, for example, nose,eyes, knuckles, elbows, knees and ankles.

In another more detailed embodiment, the therapeutic device has a thinsheet preformed body having an outer surrounding rim and a raised centerbridge portion. The rim and the bridge portion may have a common shape,for example, circular, rectangular, square or polygonal. The bridgeportion is supported by at least three legs extending upwardly from therim. The preformed body is well-suited for application to a forehead,e.g., a temple region, of the patient. Each leg may be L-shapedincluding a radial leg portion and an axial leg portion. The radial legportion extends between the bridge portion and the axial leg portion,and the axial leg portion extends between the radial leg portion and theouter rim.

In accordance with a feature of the present invention, the body of thedevice may have one or more predetermined curvatures in one or moredirections. The curvature(s) serve to ensure that the bridge portion iselevated and separated from the skin below by an air gap when the devicein its normal or neutral configuration. The curvature(s) also serve tostrengthen the bridge portion against the pull of the adhered skin whenthe device has been depressed and applied to the treatment site andallowed to rebound to or toward its neutral configuration under itsbody's shape memory. In a more detailed embodiment, the bridge portionof the device has a curvature or concavity in at least one directiontoward the inner, skin-facing surface.

The device may also be configured as a flexible band or sleeve orsemi-rigid cuff to be worn on an appendage. The body is adapted toencircle or wrap around the appendage, e.g., an arm or a leg, with aninner, skin-facing surface having at least two projections or ridgeswith an adhesive positioned therebetween for adhesion to the skin,wherein the skin is lifted when adhered to the adhesive.

The present invention also includes a method and system formanufacturing the aforementioned therapeutic device. The manufacturingprocess includes:

1. A sheet of plastic material is passed through a heating tunnel toflatten or smooth the material.

2. The material is passed through rollers, for example, silicone coatedrollers, to curve the material with a desired radius.

3. The material is passed through an adhesive applicator which appliesadhesive, including adhesive tape, with or without a release liner.

4. The material is passed through a cutting chamber, for example a dieset, which cuts bodies of the devices out of the material.

Sequence of the above steps may be varied as desired or appropriate.

The method of manufacturing may also include custom-fitting thetherapeutic device by making a mold of a body part to be fitted with thedevice and customizing the die set to the mold.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bebetter understood by reference to the following detailed descriptionwhen considered in conjunction with the accompanying drawings. It isunderstood that selected structures and features have not been shown incertain drawings so as to provide better viewing of the remainingstructures and features.

FIG. 1 is a perspective view of a hand with a cross-sectional view of aproximal portion including a median nerve and a carpal tunnel.

FIG. 2A is a top plan view of a therapeutic device, in accordance withone embodiment of the present invention.

FIG. 2B is a bottom plan view of the therapeutic device of FIG. 2A.

FIG. 2C is a lateral cross-sectional view of the therapeutic device ofFIG. 2A, taken along line C-C.

FIG. 2D is a longitudinal cross-sectional view of the therapeutic deviceof FIG. 2A, taken along line D-D.

FIG. 3 is a top plan view of the therapeutic device of FIG. 2A, asapplied to a user's palm.

FIG. 3A is a cross-sectional view of the therapeutic device of FIG. 2A,in a neutral configuration.

FIG. 3B is a cross-sectional view of the therapeutic device of FIG. 2A,in a depressed configuration.

FIG. 3C is a cross-sectional view of the therapeutic device of FIG. 2A,in an adhesion configuration.

FIG. 4A is a top plan view of a therapeutic device, in accordance withanother embodiment of the present invention.

FIG. 4B is a bottom plan view of the therapeutic device of FIG. 4A.

FIG. 4C is a lateral cross-sectional view of the therapeutic device ofFIG. 4A, taken along line C-C.

FIG. 4D is a longitudinal cross-sectional view of the therapeutic deviceof FIG. 4A, taken along line D-D.

FIG. 5A is a top plan view of a therapeutic device, in accordance withanother embodiment of the present invention.

FIG. 5B is a bottom plan view of the therapeutic device of FIG. 5A.

FIG. 5C is a lateral cross-sectional view of the therapeutic device ofFIG. 5A, taken along line C-C.

FIG. 5D is a longitudinal cross-sectional view of the therapeutic deviceof FIG. 5A, taken along line D-D.

FIG. 6 is a top plan view of the therapeutic devices of FIGS. 4A and 5A,as applied to a forehead of a user.

FIG. 7 is a schematic diagram of a system implementing a method ofmanufacture in accordance with an embodiment of present invention.

FIG. 7A is a perspective view of a machine system for manufacturing andpackaging the therapeutic device of FIG. 2A, in one stage of operationin accordance with an embodiment of the present invention.

FIG. 7B is a perspective view of the machine system of FIG. 7A inanother stage of operation in accordance with an embodiment of thepresent invention.

FIG. 8A is a perspective view of a therapeutic device, in accordancewith another embodiment of the present invention.

FIG. 8B is a top plan view of the therapeutic device of FIG. 8A, in aneutral configuration.

FIG. 8C is a bottom plan view of the therapeutic device of FIG. 8A.

FIG. 8D is a cross-sectional view of the therapeutic device of FIG. 8B,taken along line D-D.

FIG. 8E is a cross-sectional view of the therapeutic device of FIG. 8A,in a depressed configuration, as applied to skin.

FIG. 8F is a cross-sectional view of the therapeutic device of FIG. 8A,in an adhesion configuration, as applied to skin.

FIG. 8G is a cross-sectional view of a therapeutic device, in accordancewith another embodiment of the present invention.

FIG. 9 is a top plan view of the therapeutic device of FIG. 8A, asapplied to a temple region of a user.

FIG. 10 is a schematic diagram of a system for implementing a method ofmanufacturing a therapeutic device in accordance with another embodimentof the present invention.

FIG. 11 is a perspective view of a therapeutic device in accordance withanother embodiment of the present invention.

FIG. 12 is a perspective view of the devices of FIGS. 11 and 14, asapplied to forearm of a user.

FIG. 13 is a perspective view of the device of FIG. 11, as applied to athigh and a foot of a user.

FIG. 14 is a perspective view of a therapeutic device in accordance withanother embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to a device having a bridge portionadapted for releasable adherence to a patch of skin so as to lift thepatch of skin above a sensitive underlying treatment site in reducingdiscomfort or pain associated with tissue compression at the treatmentsite. The device is positioned on the patient such that the bridgeportion is elevated above the treatment site in a direction generallyperpendicular to the patch of skin with an exposed adhesive facing thepatch of skin to be lifted and/or stretched outwardly. With theapplication of pressure to elastically deform the device from itsoriginal neutral configuration, the bridge portion is brought intocontact with the patch of skin, adhering the skin to the adhesive. Whenthe pressure is removed, the device rebounds and generally reassumes itsoriginal configuration with the bridge portion lifting the attachedpatch of skin as it returns to an elevation at or near its originalelevation.

With reference to FIGS. 2A-2D, a device 200 has a thin sheet body 202with a longer length dimension L and a shorter width dimension W. Thebody 202 has an outer surface 204 and an inner (skin-contacting orskin-facing) surface 206. The body 202 may be constructed of anysuitable material with “memory” such that the body can be deformed underapplication of a force or load from an original shape or configurationand elastically return to the original shape or configuration afterremoval of the force or load. Depending on the underlying material ofwhich the body 202 is constructed, the body 202 may have a thickness Tranging between about 0.012 and 0.018 inches (0.30 mm-0.45 mm), andpreferably about 0.015 inches (0.40 mm). The body 202 may also beprovided with one or more predetermined curvatures C, such as concavityor convexity, in one or both axes L and W.

Suitable materials for the body 102 include materials that arebiocompatible or FDA-approved plastics, acrylate, polymers, metal, suchas aluminum or stainless steel, or even wood or wood composites. Apresently preferred material is polyethylene terephthalate (PET).

For use of the device 200 to treat the symptoms of CTS, the thin sheetbody 202 of the device has a “butterfly” configuration adaptedaffixation to a palm 113 of a user, as illustrated in FIG. 3. The body202 of the device 200 has two larger side support portions or “wings”120 and an elevated bridge portion 208 extending between the supportportions 120. The body 202 spans between about 1½ inches and 1¾ inches,and preferably about 1¼ inches in the direction of the shorter/widthdimension or axis W, and about 2½ inches and 2¾ inches, and preferablyabout 2¼ inches in the direction of the longer/length dimension or axisL.

In other embodiments, the body 202 has a thickness T ranging betweenabout 0.012 and 0.016 inches, and spans between about 1 inch and 1⅓inches, and preferably about 1⅕ (1.235) inches in the direction of theshorter/width dimension or axis W, and about 1⅘ inches and 2.0 inches,and preferably 1 9/10 (1.900) inches in the direction of thelonger/length dimension or axis L.

The bridge portion 208 is rectangular, being elongated along the axis Wand spanning about ⅜ inch in the L axis. Each of the side portions 220has a rounded “petal” shape with a greater outer width 221 that tapersslightly to a lesser inner width 122 adjacent the body 208.

Moreover, the body 202 is provided with at least one predeterminedcurvature relative to an axis to conform to contours of the palm 113near the wrist and location of the carpal tunnel (FIG. 1). In theillustrated embodiment of FIGS. 2C and 3, the body 202 has apredetermined concavity in the axis W toward the inner surface 206 tocorrespond with the convexity at the proximal end of the palm 113 (FIG.1). The predetermined concavity of the body relative to the axis W maygenerally trace a circle defined by a radius R ranging between about 4to 6 inch diameter, preferably about a 5 inch diameter.

The inner surface 206 of the bridge portion 208 is provided with anadhesion member or adhesive 226, for example, a coating or layer ofadhesive for releasably affixing the device 200 to the palm. Theadhesive 226 is covered and protected by a release liner 228 that isremoved prior to use of the device 200 and application onto the user'sskin.

With reference to FIGS. 3 and 3A-3C, use of the device 200 is describedas follows. After the release liner 228 has been removed to expose theadhesive 226, the device 200 is placed over the palm 113 with the innersurface 106 and the adhesive 226 facing the palm 113. The device 200 isoriented with its longer axis L being generally transverse to middlefinger 114. As shown in FIG. 3A, the device is positioned with each wingportion 220 resting on a respective convexity of the palm near muscles102 and 104. With the device in its original and neutral configuration,the bridge portion 208 spans linearly in between the muscles 102 and104, and elevated from the recess 112 and the median nerve 118.Advantageously, the slight but predetermined concavity of the device 100in the lateral or W axis (FIG. 2C) enables the device to conform to theconvexity of the palm 113, with the bridge portion 108 being elevatedand separated from the skin below by an air gap G. As shown in FIG. 3B,to apply the device, pressure P is then applied, for example, by theuser's other hand or that of an assistant, to the outer surface 204 ofthe bridge portion 208 above the adhesive 226 toward the skin so as todeform the bridge portion 208 (and any other portions of the body 202),bring the adhesive 226 into contact with the skin and allow the adhesive226 to adhere to the skin, reducing or eliminating the air gap G.

When the pressure P is removed and the body 202 is released, theelastically deformable body 202 generally returns to its originalneutral state in reassuming the predetermined concavity and thelinearity between the bridge portion 208 and the wing portions 220, withat least a portion of the skin of the recess 112 adhering to theadhesive 226, as shown in FIG. 3C. Advantageously, the linearity or“bridging” of the bridge portion 208 when the body 202 rebounds pullsthe adhered skin and adjacent tissue in the region of the recess 112outwardly or away from the median nerve 118 to result in negativepressure and reduction of compression of the median nerve. In accordancewith a feature of the invention, the lifted skin or tissue may be raisedor repositioned from its original position a distance ranging between1.0 mm to 5 mm, preferably 2.0 mm to 4.0 mm, and more preferably about3.0 mm. To that end, the concavity of the body 202 which extends acrossthe bridge portion 208 further strengthens the bridge portion 208 whenlifting the skin against the pull of adjacent skin. Moreover, opposingends 208E of the portion 208, each with three sides unattached to thebody 102, allow the device 200 to be more flexible and comfortable whileaffixed to the palm, while providing additional bridging strength to thebridge portion 208 against the pull of adjacent skin, as well asproviding additional surface area for the adhesive 226 to adhere withthe skin.

In the disclosed embodiment, the bridge portion 208 is adhered to theskin, whereas the wing portions 220 are without adhesive and are notattached but are free to move and slide relative to the skin. Thisfreedom of movement increases comfort to the user of the device byminimizing pinching or poking that may otherwise resulting discomfort ifthe wing portions (or any portions thereof) were also adhered to theskin. In that regard, a layer of fabric or liner or a coating offriction reducing gel may be provided on the inner surface of the wingportions 220 to prevent chafing. However, it is understood that theadhesive and adhesion member may be applied to one or more regions onthe inner surface of the body and configured to cover beyond the bridgeportion, for example, all or portion(s) of each or both wing portions220.

It is understood that the bridge portion 208 need not be centeredbetween the wing portions 220. That is, the size and/or shape of eachwing portion 220 need not be equal or matching to the other. One wingmay be larger, wider and/or longer than the other, as need orappropriate. There need not be symmetry about the axis L or W.

In an alternative embodiment of the present invention, a device 300 totreat the symptoms of a migraine headache is illustrated in FIGS. 4A-4D.Similarities between the devices 200 and 300 (as well as other devicesdescribed herein) are denoted by similar reference numerals. However,each device has different adaptations for application and affixation tothe patient's body. For example, the device 300 has adaptations forapplication and affixation to a generally flat skin site such asforehead 130 (FIG. 6), although it is understood that the device 200 mayalso be used to treat migraine headaches. A body 302 of the device 300has a generally rectangular configuration with rounded corner 340, and abridge portion 308 contiguous with two opposing rectangular or squareside support portions 320. The body 302 spans between about ¾ inches and1¼ inches, and preferably about 1.0 inches in the direction of theshorter/width dimension or axis W, and about 2.0 inches and 2½ inches,and preferably about 2¼ inches in the direction of the longer/lengthdimension or axis L. The bridge portion 308 is rectangular, beingelongated relative to the axis W and spanning about ⅜ inch in the Laxis.

The body 302 has at least two predetermined curvatures (same ordifferent degree of curvatures), one in the axis W (FIG. 4C) and anotherin the axis L (FIG. 4D), to provide concavity toward the inner surface304 in at least two directions.

In another embodiment of the present invention for treatment of migrainesymptoms, especially in the center of the forehead above the nose asillustrated in FIG. 6, a similar device 300′ of FIGS. 5A-5D may have oneor more arcuate longitudinal edges 342 which can accommodate placementof the device around eyes, nose or ears.

For either device 300 or 300′, inner surface 206 of the bridge portion208 is provided with adhesion member or adhesive, which may include oneor more suction cups 330 (FIGS. 4A-4D) or micro suction cup tape 332(FIGS. 5A-5D) having a surface with a multitude of microscopic craters334 that work by creating many partial vacuums between the tape andtarget surface. The tape 332 can rebond repeatedly, and leaves noresidue on the skin. A preferred tape is No. MSX-6800, DC ConformableHi-Tack Type tape manufactured by 3M.

Moreover, for either device 300 or 300′, on the inner surface 306 at ornear lateral edges 344, each side support portion 320 includes aprojection, such as a raised ridge 346 with a height H (FIGS. 5A-5B)which elevates the body 302 away from the skin so that the bridgeportion 308 forms a bridge that is separated from the skin with an airgap in between. In that regard, the body 302 has sufficient rigidity toprovide linearity between the portions 308 and 320. Each ridge 346 mayhave a different height, depending on the contour of the site. Theridges 346 may be constructed of the same material as the body 302 or ofany other suitable material that provides sufficient form and structureto lift the body 302. Where the body 302 spans about 1 7/16 inches alongthe axis L, and about 1 3/16 inches along the axis W, each ridge 346 mayhave a thickness of about 3/16 inch and a width ranging between about ⅛inch and ¼ inch. Ends of each ridge may terminate a distance of about ⅛inch from the longitudinal edges 240.

It is noted that the concavity/ies of the bodies (actual or aseffectuated by the ridges 346) should be of a sufficient degree suchthat peripheral edges, including longitudinal edges 340 and lateraledges 344 extend beyond the adhesive (e.g., adhesive coating, adhesivetape, suction cups, or micro-suction cup tape) so as to elevate theadhesive from skin and provide an initial air gap before the skin isadhered to the device (as shown in FIGS. 4C, 4D and 5D).

In use, the adhesive 326 is exposed and the device 300′ is placed overthe target skin site with the inner surface 306 and the adhesive 326facing the skin. The device 300 is oriented with the ridges 346straddling the skin site so that the bridge portion 308 and the adhesive326 is directly over the sensitive skin site. Elevated by the ridges346, the bridge portion 308 is situated above the skin, separated by anair gap. With the device so positioned, pressure is then applied by theuser (or an assistant) to the outer surface 304 of the bridge portion208 directly above the adhesive 326 toward the skin so as to deform thebridge portion 308 (and any other portions of the body 302), bring itinto contact with the skin and allow the adhesive 326 to adhere to theskin.

When the pressure is removed and the body 302 is released, theelastically deformable body 302 generally returns to its originalneutral state in reassuming the linearity between the bridge portion 308and the side portions 320, thereby lifting the adhered skin and tissueand reducing compression at the site. The device can be situated aroundthe eyes, near a temple, or above the nose on the forehead, asfacilitated by the arcuate longitudinal edges 240, as shown in FIG. 6.

With reference to FIG. 7, the foregoing devices may be manufactured inaccordance with the following method:

1. Providing a single flat sheet 150 of suitable material;

2. Heating the sheet to smooth the sheet 150 and remove wrinkles andbends;

3. Stamping, die-cutting or otherwise cutting the sheet 150 to form thedevice.

4. Applying the adhesive to the inner surface of the bridge portion.

The method may include forming the sheet 270 with at least onepredetermined curvature.

Heating the sheet may include passing the sheet 170 through a heattunnel 151, and/or under or between heated roller(s) 152. Forming thesheet 150 with at least one predetermined curvature may include passingthe sheet through heated roller(s) 154. Stamping, die-cutting orotherwise cutting the sheet into device bodies may be performed by a dieset including roller 154 and a movable punch 156. The movable punch 156may be curved to conform to the curvature of the roller 154 tosimultaneously form the device body with at least one or morepredetermined curvature. Applying the adhesive 326 may occur at anystage, including before, during or after stamping, die-cutting orotherwise cutting the sheet. As mentioned, the adhesive may be medicalgrade adhesive suitable for topical use. It may take the form of a solidcoating or layer (or a plurality of adhesive lines), double-sidedadhesive tape, suction cup(s) or micro-suction cup tape. Any releaseliner may be applied simultaneously with the application of the adhesiveor afterwards.

Where the device has ridges 246, the die set may have formations tostamp the ridges into the sheet, or they may be mounted after stamping.Alternatively, the method of manufacture may include applying oradhering the ridges 246 to the inner surface of the bridge portionbefore, during or after application of the adhesive to the innersurface.

An embodiment of a machine system 160 implementing a method ofmanufacture and packaging of the device is illustrated in FIGS. 7A and7B. The machine system 160 includes a longitudinal conveying platform161 that defines a conveying pathway P from a first end 162 downstreamto a second end 164. At or near the first end 162 is dispenser roller166 of sheet material 167. Stored in roll form, the sheet materialadvantageously has a preformed curvature. To that end, the dispenserroller 166 in one embodiment of the invention has an initial diameter nogreater than about 25 inches and more preferably no greater than about20 inches.

Downstream of the dispenser roller 166 is a smooth roller 168 positionedto flatten the sheet material and remove wrinkles or bumps. Downstreamof the smooth roller 168 is an adhesive tape applicator roller 172 whichapplies double-sided adhesive tape strips 174 onto an upward surface 175of the sheet material (which becomes the inner/skin-facing surface ofthe device). The tape strips 174 are mounted on the applicator roller172 with an exposed adhesive surface 171 facing outwardly so that itcontacts and affixes to the upward surface 175 of the sheet material 167upon pressure applied by the roller 172. Release liner strips 173 areaffixed to the opposing surface of the applied tape strips 174 forsubsequent removal by users when applying the devices.

Downstream of the applicator roller 172 is a die press 179 with upperplaten 176 and lower platens 178A and 178B driven by air hydraulicsassembly 180. The upper platen 176 is driven toward first lower platen178A in a first stage operation of the die press and toward the secondlower platen 178B in a second stage operation of the die press, asdescribed below, to die cut a plurality of individual devices 10A and10B from the sheet material 167 and the tape strips 174 affixed thereon.

The lower platens 178A and 178B are supported on a carrier 182 that isadapted for translational movement in opposition directions T1 and T2along a pathway generally transverse to the conveying pathway P. In afirst stage operation (FIG. 7A), the carrier 182 slides in direction T1to position the first lower platen 178A directly below the upper platen176 wherein the upper platen 176 engages the first lower platen 178A andcuts devices 10A in die recesses 181A, exposing the second lower platen178B off one side of the conveying platform 161 and rendering itaccessible to a transport member 184B. In the second stage (FIG. 7B),the carrier 182 slides in direction T2 to position the second lowerplaten 178B directly below the upper platen 176, wherein the upperplaten 176 engages the second lower platen 178B and cuts devices 10B indie recesses 181B, exposing the first lower platen 178A off the oppositeside of the conveying platform 161 and rendering it accessible to anopposing transport member 184A. Accordingly, the carrier 182 translateseach lower platen 178A and 178B between an engagement position under theupper platen 176 and an unload position under respective a transportmember 184A. Where a full die cut cycle of the die press involves thefirst stage operation followed by the second stage operation insequence, the hydraulics assembly drives the die press 179 and carrier182 in a manner whereby one of the lower platen is placed under theupper platen 176 for die cutting and while the other lower platen isexposed and accessible to a respective transport member 184. That is, inone stage of operation, the one lower platen is in the engagementposition whereas the other lower platen is in the unload position, andin the other stage of operation, the other lower platen is in theengagement position whereas the one lower platen is in the unloadposition.

In addition to driving the die press 179 and the carrier 182, thehydraulics assembly 180 also drives support arms 185 to move thetransport members 184A and 184B between at least three positions: a waitposition, a load position, and an off-load position. The transportmembers are adapted to secure a load of devices and transport thedevices from the lower platens 178A and 178B to packaging or dispensers183 arranged on tray members 186A and 186B arranged below the lowerplatens in their exposed positions. As shown in FIG. 7A, when lowerplaten 178B is exposed and accessible to transport member 184B, thetransport member 184 is actuated by the hydraulics assembly 180 to movefrom its wait position to the load position where it picks up devices10B from the lower platen 178B. In the illustrated embodiment, thetransport member 184 includes grippers with vacuum/suction cups 189mounted on posts 190 which are activated to grab the devices 10Bindividually. With a load of devices on board, the transport member 184Bis actuated by the hydraulics assembly 180 to move into the off-loadposition toward the tray member 186B positioned below the exposedposition of the lower platen 176B and release the devices 10B intodispensers 183B. The transport member 184B is then returned to its waitposition for the next cycle when the lower platen 176B contains more cutdevices and is exposed and accessible again.

The tray member 186B is supported on carrier 188B which translates thetray member 186B along direction C parallel with the conveying pathway Pso that the tray member 186B can shift between different positions forefficient loading of the dispensers 184. In the illustrated embodiment,the tray member is translated between two positions: a proximal positionand a distal position.

It is understood that the actuation and movement of the die press 179,the carrier 182, the transport members 184A and 184B and the carriers188 may be coordinated and synchronized with each other, as desired orappropriate for efficient operation of the machine system. For example,the upper platen 176 may be driven to engage lower platen 178A as thesupport arm 185B is driven to pick up devices 10B from the lower platen178B, and as the support arm 185A is releasing devices into thedispensers 181A. A suitable system and machine for transporting workpieces is described in U.S. Pat. No. 8,230,989, entitled SHUTTLE MACHINEFOR MACHINE TOOL, the entire contents of which are hereby incorporatedby reference.

The spent sheet material 167 downstream of the die press 179 is drawndownstream by a servo drive rollers 190 and collected on a waste roller192 at the second end 164 of the conveying platform 161.

Another embodiment of the present invention is illustrated in FIGS.8A-8C. A device 400 has a thin sheet body 402 which has been formed witha raised center profile. The body 402 has a support portion 402 and anelevated planar center bridge portion 408. The support portion 402 isadapted to rest on skin above a sensitive underlying site, such astemple 132, as shown in FIG. 9. The support portion 402 includes anouter rim or base 450 and radially extending L-shaped legs or posts 454projecting therefrom that connect the base 450 and the bridge portion408. The base 450 is adapted to rest on and generally surround skin of asensitive underlying site, such as temple 132, as shown in FIG. 9.Between adjacent pairs of legs is an opening 456. As better seen inFIGS. 8D-8F, each leg has a radial portion 460 coplanar with the bridgeportion 408 and an axial portion 462 extending between the radialportion and the base 450. The axial portion 462 may extend at an angleranging between about 45 to 120 degrees, preferably about 60 to 100degrees, and more preferably about 90 degrees, from the base 450. Theplurality of legs 454 ranges between about two and five.

With reference to FIGS. 8A-8F, the illustrated embodiment of the devicehas three legs 454 positioned equidistance from each other (e.g.,centered at about 0, 120 and 240 degrees), and three openings 456.Moreover, each leg presents a 90 degree angle between the radial portion460 and the axial portion 462, and also between the axial portion 462and the base 450. Width of the legs can vary depending on the pluralityof legs and the desired flexibility of the bridge portion 408. An innersurface 406 of the bridge portion 408 has an adhesion member or adhesive426, for example, a coating or layer of adhesive, an adhesive tape or amicro suction cup tape, as described above. An inner surface of the rim450 may also be provided with an adhesion member or adhesive to helpsecure the device on the skin.

In one embodiment, the outer radius r of the base 450 is 1.375 inches,the radius R of the bridge portion 408 is 0.5 inch, the width WA of theaxial portion 462 is 0.625 inch, and the width WB of the base 450 is0.125 inch. The height H of the bridge portion 408 from the base 450 is0.1875 inch and the thickness of the body 402 throughout the device 10is 0.015 inch.

The base 450 and the bridge portion 408 may each be any shape, forexample, rectangular, polygonal, oval, or circular. In the illustratedembodiment, both the base and the bridge portion are circular.

In use, the adhesive 426 is exposed and the device 400 is placed overthe target skin site with the base generally surrounding the site andthe adhesive 426 facing the skin and tissue, as shown in FIG. 8D.Elevated by the legs 454, the bridge portion 408 is situated above theskin, separated by an air gap generally equal to the height H. With thedevice so positioned, pressure P is applied by the user (or anassistant) to the outer surface 404 of the bridge portion 408 toward theskin so as to deform the upper body 452 (including the bridge portion408 and/or any of the legs 454), bring the bridge portion 408 intocontact with the skin and allow the adhesive 426 to adhere to the skin,as shown in FIG. 8E.

When the pressure is removed and the upper body 452 is released, theelastically deformable body 402 rebounds and generally returns to anelevation at or near its original elevation wherein the bridge portion408 lifts the adhered skin and tissue and reducing compression at thesite.

As shown in FIG. 8D, the bridge portion 408 and the radial leg portion460 may extend perpendicularly relative to the axial leg portion 462, orthe portions 408 and 460 may have at least one predetermined curvaturein a direction. As illustrated in FIG. 8F, device 400′ has an upper body462′ with curvature in more than on axial direction to provide aconcavity toward the inner surface 406 that forms an elevated dome.

The devices of the present invention may be worn at all times, or only aspecified time periods, such as night time, during sleep. Each devicemay be reused so long as the adhesive is functional. If not, the devicemay be discarded, or new adhesive may be applied to the device over orin place of the spent adhesive. Due to the inexpensive cost of thedevice and its components, the device may be economically discarded astrash or for recycling.

With reference to FIG. 10, the device 400 can be manufactured asfollows:

1. Forming the device;

-   -   (a) Injection, press or vacuum forming the base 450, bridge        portion 408 and the legs 454; or    -   (b) Providing a single flat sheet 470 of suitable material;        -   (i) Heating the sheet to smooth the sheet 370 and remove            wrinkles or bends;            -   1. Heating by passing through a heat tunnel 471; and/or            -   2. Heating by heated roller(s) 472.        -   (ii) Stamping, die-cutting or otherwise cutting sheet to            form the base 450, the bridge portion 408 and the legs 454;            -   1. Die punching out the openings 456 to form the legs                with die set 473;

2. Applying the adhesive 426 to the inner surface 406 of the bridgeportion 408.

The stamping, die-cutting or otherwise cutting of the sheet may includeboth cutting of the base 450, bridge portion 408 and legs 454 from thesheet and reforming/reshaping to provide the curvature of the upper body452 and/or angulation or bend in the leg 454 for elevating the bridgeportion 408 from the base 450. The application of the adhesive 426 mayoccur before, during or after stamping, die-cutting or otherwise cuttingof the sheet.

In yet another embodiment of the present invention, a device 500 may beworn as a band or sleeve encircling a limb or a portion thereof. Withreference to FIG. 10, the device 500 is elongated defining a length axisL and a width axis W. The device 500 has a generally rigid yet flexiblemain body 511 having a planar, generally rectangular form, and twofastening side portions 513, each having a generally rectangular formand adjoined to an opposing side edge 515 of the main body 511. The mainbody 511 may be constructed of the same aforementioned suitablematerials. The side portion 513 may be constructed of an elastic,stretchable material or fabric. On an inner surface 506 of the main body511, an adhesion member 526 is provided and situated between at leasttwo projections 546 defining an elevated bridge portion 508.

In use, the device 500 is positioned on a limb, for example, a forearm(FIG. 12), a thigh or a foot (FIG. 13), with the exposed adhesion member526 and projections 546 facing the skin above the treatment site. Theside portions 513 are wrapped around the limb and releasably fastened toeach other by fasteners 517, e.g., hook and loop fasteners, eye and hookfasteners, snap fasteners, etc. The device 500 in a neutralconfiguration presents the bridge portion 508 at an elevated positionabove the skin, the two separated by an air gap. When pressure isapplied to outer surface 504 of the bridge portion 508, the deviceassumes a deformed configuration so that the adhesion member comes 526into contact with the skin. When the pressure is removed, the devicerebounds and the skin is lifted by the bridge portion. The device 500may have a slight predetermined curvature or concavity in the L axistoward the inner surface 506 to better conform to the limb.

In a further embodiment of the present invention, a device 500′ may beworn as a cuff on the wrist, as shown in FIG. 12. The device 500′, asillustrated in FIG. 11, has a construction similar to that of the device500 of FIG. 10, except that the device is smaller and has a pronouncedpredetermined curvature or concavity in the L axis toward the innersurface 506 to better conform to the wrist.

The present invention also includes a method of manufacturing acustom-fitted therapeutic device, wherein a mold of the treatment site,e.g., a palm, a forearm, a thigh, is made and a die set formanufacturing the device is customized according to the mold.

The preceding description has been presented with reference to presentlypreferred embodiments of the invention. Workers skilled in the art andtechnology to which this invention pertains will appreciate thatalterations and changes in the described structure may be practicedwithout meaningfully departing from the principal, spirit and scope ofthis invention. As understood by one of ordinary skill in the art, thedrawings are not necessarily to scale. Dimensions of the devices may bemodified to fit different sized users. As noted above, the device mayhave more than one adhesive or adhesive member which may be applied todifferent areas of the device beyond the bridge portion. Accordingly,the foregoing description should not be read as pertaining only to theprecise structures described and illustrated in the accompanyingdrawings, but rather should be read consistent with and as support tothe following claims which are to have their fullest and fair scope.

What is claimed is:
 1. A therapeutic device adapted for reducing painassociated with Carpal Tunnel Syndrome by lifting skin above a mediannerve in the palm of a human hand, comprising: a generally rigid butelastically deformable sheet body having a first surface and a secondsurface, the sheet body defining a longitudinal dimension and a lateraldimension, the sheet body having: a bridge having a first surface withadhesive adapted for adhesion to skin above the median nerve in thepalm; and two support wings extending outwardly from the bridge inopposite directions along the longitudinal dimension, each wing having arounded outer free edge, wherein the bridge is narrower than each wingin the longitudinal dimension, wherein the bridge has a greater lengthin the lateral dimension than each of the two support wings at ajunction with the bridge; wherein a first wing of the two support wingsis adapted to rest generally above a first muscle of the palm and asecond wing of the two support wings is adapted to rest generally abovea second muscle of the palm; wherein the two support wings are free ofadhesive; and wherein the sheet body is configured to assume a neutralconfiguration prior to affixation of the first surface of the bridge tothe skin between the first and second muscles, a depressed positionduring affixation of the first surface to the skin, and an adhesionconfiguration after affixation of the first surface to the skin.
 2. Thetherapeutic device of claim 1, wherein the sheet body has apredetermined concavity in the lateral dimension toward the firstsurface.
 3. The therapeutic device of claim 1, wherein the sheet bodyspans between about 2½ inches and 2¾ inches in the longitudinaldimension and between about 1½ inches and 1¾ inches in the lateraldimension.
 4. The therapeutic device of claim 1, wherein the bridgespans about ⅜ inches in the longitudinal dimension of the sheet body. 5.The therapeutic device of claim 1, wherein the bridge is generallyrectangular with a length and a width, the length extending in thelateral dimension and the width extending in the longitudinal dimension.6. The therapeutic device of claim 1, wherein the bridge is adapted tobe positioned linearly in between an abductor digit minimi muscle and anabductor policis brevis muscle of the human hand.